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INITIATE (INITiate Insulin by Aggressive Titration and Education). A randomized study to compare initiation of insulin combination therapy in type 2 diabetic patients individually and in groups

¹University of Helsinki, Helsinki, Finland
²Minerva Institute for Medical Research, Helsinki, Finland
³Endocrinology, Metabolism and Diabetes, Karolinska University Hospital, Stockholm, Sweden
⁴Swan Lane Medical Centre, Bolton, UK
⁵Leicester Royal Infirmary, Leicester, UK
⁶sanofi-aventis, Helsinki, Finland
⁷VU University Medical Center, Amsterdam, Netherlands
⁸Turku Health Center, Turku, Finland

ykijarvi{at}cc.helsinki.fi

ABSTRACT

Background.: Insulin is often postponed for years because initiation is time-consuming.

Objectives.: To compare initiation of insulin individually (IND) and in groups (GROUP) with respect to change in HbA_1c and several other parameters in type 2 diabetic patients.

Design:: A randomized (1:1), multi-center two-arm parallel design study with a recruiting period of up to 14 weeks and a 24-week treatment period. 121 insulin-naïve type 2 diabetic patients with an HbA_1c of 7.0-12.0 % were randomized to initiate bedtime insulin glargine either in groups of 4-8 or individually using the same personnel and education program. The patients visited the treatment center before, at the time of insulin initiation and at 6, 12 and 24 weeks. Patients self-adjusted the insulin dose to achieve a fasting plasma glucose of 4.0-5.5 mmol/l.

Results.: At 24 weeks, HbA_1c had decreased from 8.7±0.2 to 6.9±0.1% in IND and from 8.8±0.2 to 6.8±0.1% in GROUP (NS).Insulin doses averaged 62±5 IU and 56±5 IU at 24 weeks (NS), respectively. The frequency of hypoglycemia was similar. The total time (visits and phone calls) spent in initiating insulin in GROUP (2.2±0.1 hrs) was 48% less than in IND (4.2±0.2 hrs). Diabetes treatment satisfaction improved significantly in both groups.

Conclusions.: Similar glycemic control and treatment satisfaction can be achieved by initiating insulin in groups and individually. Starting insulin in groups takes half as much time as individual initiation.

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